Exercise Training to Lose Weight in Obese Asthmatics

NCT02188940 | Completed DMC

• 2 other identifiers: ETLWOA2012/16700-9
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

Obese asthmatics have more severe symptoms, reduced lung function, poorer quality of life and a reduced response to inhaled corticosteroid medication compared to non-obese asthmatics. In addition, the impact of a weight-loss program on clinical control and psychological outcomes has been poorly demonstrated and the effect of exercise training remain unknown. The investigators aim to investigate the effect of exercise training in a weight-loss program on asthma clinical control (primary outcome), health factors related to quality of life and psychosocial symptoms (secondary outcomes) in obese patients with moderate-to-severe persistent asthma. Physical activity, inflammatory profiles and sleep disorders will also be evaluated. The investigators' hypothesis is that exercise as part of a weight-loss program is more effective to lose weight and improve asthma control, quality of life and psychosocial symptoms in obese asthmatics.

Conditions

Asthma; Obesity

Keywords

Asthma; Obesity; Clinical control; Exercise; Weight-loss

Outcome Measures

Primary Outcomes (1)

• Clinical Control

  Clinical control will be evaluated by asthma control questionnaire (ACQ)

  Before and after 3 months of intervention

Secondary Outcomes (2)

• Health related quality of life

  Before and after 3 months of intervention

• Level of depression and anxiety

  Before and after 3 months of intervention

Other Outcomes (8)

• Airway inflammation

  Before and after 3 months of intervention

• serum cytokines and adipokines levels

  Before and after 3 months of intervention

• Daily life physical activity

  Before and after 3 months of intervention

Study Arms (2)

Exercise, dietary and behavioral therapy

ACTIVE COMPARATOR

The interventions of active comparator will be education program, dietary and behavioral therapy and exercise training.

Behavioral: Dietary; Behavioral: Education Program; Behavioral: Behavioral Therapy; Other: Exercise Training

Dietary and behavioral therapy

SHAM COMPARATOR

The intervention in sham comparator will be education program, dietary and behavioral therapy and stretching and breathing exercise.

Behavioral: Dietary; Behavioral: Education Program; Behavioral: Behavioral Therapy; Other: Stretching and Breathing exercise

Interventions

Dietary BEHAVIORAL

The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.

Dietary and behavioral therapy; Exercise, dietary and behavioral therapy

Education Program BEHAVIORAL

The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.

Dietary and behavioral therapy; Exercise, dietary and behavioral therapy

Behavioral Therapy BEHAVIORAL

The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.

Dietary and behavioral therapy; Exercise, dietary and behavioral therapy

Exercise Training OTHER

The aerobic training will be performed on a treadmill and a bike (or an elliptical), twice a week, totaling 24 sessions of 60 minutes each. The initial intensity will be 50% to 60% of VO2 max reaching a maximal 75% of VO2 max and the progression will take place according to the level of effort (Borg) in the last two sessions. Patients will be advised to walk outside at least twice a week for 30 minutes and write down their activity in a diary. Furthermore, they will be given an accelerometer in week 6 to record their daily steps. The resistance training will consist of exercises for the upper and lower limbs. Initially, the patients will perform 2 sets of 10 repetitions with load of 50% to 70% of 1-RM and the progression will take place in the number of repetition, and then in the load.

Exercise, dietary and behavioral therapy

Stretching and Breathing exercise OTHER

Breathing exercise will consist of 3 exercises adapted from yoga's breathing technique (kapalabhati, uddhiyana and agnisara) twice a week, totaling 24 sessions of 30 minutes each. Every exercise will be performed in sets of 3 (2 minutes each) with 60 seconds of rest between them. The stretching will consist of stretching exercises for the major muscle groups in 3 sets of 10 seconds each. The program will be performed twice a week, totaling 24 sessions of 30 minutes each. \*Both breathing and stretching exercises will be performed as placebo to ensure the same duration of treatment between the two groups.

Dietary and behavioral therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Asthma moderate and severe
• Asthma will diagnosed (Global Initiative for Asthma -GINA)
• Body Mass Index between 35 kg/ m2 and 39,9 kg/m2
• Sedentary
• Medical treatment, for at least 6 months
• Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

You may not qualify if:

• Cardiovascular, musculoskeletal or other chronic lung diseases
• Active Cancer
• Pregnant
• Weight loss more than 5 % in the preceding 6 months
• Using weight-loss medications
• History of bariatric surgery, uncontrolled hypertension or diabetes
• Using overnight continuous positive airway pressure
• Lactating
• Current or ex-smoker

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Clinical Hospital of São Paulo University medical school (HCFMUSP)

São Paulo, São Paulo, 05360-160, Brazil

Location

Related Publications (2)

• Freitas PD, Ferreira PG, Silva AG, Stelmach R, Carvalho-Pinto RM, Fernandes FL, Mancini MC, Sato MN, Martins MA, Carvalho CR. The Role of Exercise in a Weight-Loss Program on Clinical Control in Obese Adults with Asthma. A Randomized Controlled Trial. Am J Respir Crit Care Med. 2017 Jan 1;195(1):32-42. doi: 10.1164/rccm.201603-0446OC.

  PMID: 27744739 DERIVED

• Freitas PD, Ferreira PG, da Silva A, Trecco S, Stelmach R, Cukier A, Carvalho-Pinto R, Salge JM, Fernandes FL, Mancini MC, Martins MA, Carvalho CR. The effects of exercise training in a weight loss lifestyle intervention on asthma control, quality of life and psychosocial symptoms in adult obese asthmatics: protocol of a randomized controlled trial. BMC Pulm Med. 2015 Oct 21;15:124. doi: 10.1186/s12890-015-0111-2.

  PMID: 26487563 DERIVED

MeSH Terms

Conditions

Asthma; Obesity; Motor Activity; Weight Loss

Interventions

Diet; Early Intervention, Educational; Behavior Therapy; Exercise; Breathing Exercises

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Celso RF Carvalho, PhD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 14, 2014
• Study Start: July 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 22, 2016

Record last verified: 2014-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)